Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
Applications submitted to MHRA for a marketing authorisation for a medicinal product must state the legal basis under which the application is made.
Information on the safety of medicine use during pregnancy is limited at the time of marketing, making post-marketing surveillance essential.
The MHRA will help shape international rules for AI in healthcare – speeding up access to safe, effective technologies into the NHS and worldwide.
And much more...
Applications submitted to MHRA for a marketing authorisation for a medicinal product must state the legal basis under which the application is made. The available legal bases are set out in the Human Medicines Regulations 2012 (as amended) (‘the HMRs’).
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.
The European Medicines Agency (EMA) has implemented exceptional measures to maximise the transparency of its regulatory activities on COVID-19 medicines, during and after the COVID-19 public health emergency. These measures have supported public health efforts, fostered trust and enabled informed decision-making.
The MHRA will help shape international rules for AI in healthcare – speeding up access to safe, effective technologies into the NHS and worldwide.
If an individual is at all susceptible to mental unwellness, overuse of a talkative LLM could push him or her over the edge. Maybe literally.
As chief data and AI officer at Ann & Robert H. Lurie Children's Hospital of Chicago, Rajiv Kolagani is building a state-of-the-art data platform that harnesses artificial intelligence to elevate clinical quality, drive operational excellence and enhance the experience of providers, patients and families.
Information on the safety of medicine use during pregnancy is limited at the time of marketing, making post-marketing surveillance essential. However, the lack of a specific indicator for pregnancy-related case reports within the international standard for transmission of individual case safety reports complicates the retrieval of such reports in pharmacovigilance databases.
The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies.
Adverse drug events (ADEs) are events occurring after the administration of a drug. Several authorities are involved in capturing these ADEs to improve pharmacovigilance. These ADEs are reported directly to healthcare professionals or via the telephone, online, or e-mail and are crucial for maintaining drug safety.
Pictures used in this newsletter were generated by AI.